Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT06478108

Interventional Software for Multi-immunotherapy of Solid Tumors

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-27

60

Participants Needed

1

Research Sites

508 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Guangzhou Medical University

Lead Sponsor

I

Immuno (Guangzhou) Biomedicine S&T Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and/or PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.

CONDITIONS

Official Title

Interventional Software for Multi-immunotherapy of Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of cancer by cytohistology
  • Signed informed consent before joining the trial
  • Age over 18 years with expected survival longer than 3 months
  • Child-Pugh class A or B with Child score over 7; ECOG score less than 2
  • Acceptable coagulation function or reversible coagulation disorders
  • Laboratory tests within 7 days before procedure meeting specified blood counts and organ function levels
  • At least one measurable tumor lesion according to RECIST v1.1
  • Use of birth control methods
  • Willingness and ability to comply with visits, treatment, and laboratory tests
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial of equipment or drugs within the last 4 weeks
  • Presence of ascites, hepatic encephalopathy, or bleeding from esophageal or gastric varices
  • Serious accompanying diseases affecting prognosis such as heart disease, uncontrolled diabetes, or psychiatric disorders
  • History or presence of other tumors or malignancies
  • Pregnancy or lactation without use of birth control during treatment
  • Poor compliance with treatment or study requirements
  • Contraindications for hepatic arterial infusion including impaired clotting, renal failure requiring dialysis, severe atheromatosis, uncontrolled hypertension above 160/100 mmHg
  • Allergy to contrast agents
  • Use of agents affecting absorption or pharmacokinetics of study drugs
  • Any other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

Z

Zhenfeng Zhang, MD, PhD

CONTACT

B

Bingjia He, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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